Recurring concern

Failure to provide safety warnings at point of sale for hazardous products and equipment

Pin Get email alerts Request correction

First reported 21 Jul 2017•Latest report 11 Apr 2025

Definition

What this concern includes

Includes failures of retail or online point-of-sale arrangements to provide, require or make available clear safety warnings or use guidance for products or equipment presenting a material public-safety risk, including warnings about water conditions and safety equipment for paddleboards, fire risks from paraffin-containing emollients, and restraint or strangulation risks from high-risk lap belts.

Not included

  • Excludes product-packaging or enclosed-information warnings where no point-of-sale warning or purchaser-facing sales process is identified; those belong to the existing product-safety-labelling concern.
  • Excludes neutral product information, ordinary instructions or general consumer advice where no serious safety hazard is communicated.
  • Excludes restrictions on access, suitability assessments or regulation of product sales when the failure is not the absence or unreliability of purchaser-facing safety warnings.
  • Excludes warnings directed solely to professionals or staff when purchasers are not the relevant recipients.
Reports
4

Distinct published reports

Individual concerns
4

A report can raise multiple concerns

Date range
2017–2025

First to latest report issue date

Stated actions
15

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Department of Health and Social Care3
Medicines and Healthcare products Regulatory Agency3
NHS England2
Proprietary Association of Great Britain2
Alliance Pharmaceuticals Limited1
Arjo UK Limited1
Bayer plc1
Bradford District Care NHS Foundation Trust1
Care Quality Commission1
Homecare Association Limited1
Locala Community Partnerships C.I.C.1
Prime Minister's Office, 10 Downing Street1
Public Ltd1
Tesco PLC1
Thornton & Ross Limited1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. Rutland and North Leicestershire

    AI-generated summary

    Susan Marion LAKIN · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Susan Marion Lakin, a 72-year-old woman with progressive mobility and memory decline, died after sliding beneath an armchair lap belt that became caught around her neck. The report raises concerns that high-risk lap belts were available to purchase online without adequate warnings about risks such as strangulation or guidance from a healthcare professional.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to provide purchasers with warnings about the risks of high-risk lap belts

    Wider context from the report

    “The advertisement and sales particulars for the lap belt that they purchased states “fits any armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient will... suffer any injuries, tilting or slipping”. The advertisement and sales particulars contain no warning about the risks that are associated with the use of the lap belt, nor any suggestion that the lap belt should be used or fitted under the guidance/supervision of a therapist or medical professional. The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation. It is concerning that people who have no healthcare training at all can purchase high risk equipment for their loved ones online without being appraised of those risks or even being informed about the high risk nature of the equipment. Lap belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with the use of the same. ”

    Source location

    Susan Marion LAKIN · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Publish a product safety report warning about the ORTONES belt and documenting the corrective action taken.

    Verbatim wording from the response

    “These steps should ensure the product is no longer available to purchase in the UK. On 31 October, OPSS published a product safety report for the ORTONES belt on the Product”

    Source location

    Response from Office for Product Safety and Standards
    Page 1 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review wider intelligence on wheelchair and armchair support belts, including incidents, standards and product instructions and warnings.

    Verbatim wording from the response

    “Alongside the steps to reduce the risk to consumers posed by the ORTONES belt, OPSS has been gathering wider intelligence into wheelchair/armchair support belt products. There is a broad range of similar support belts and harnesses available to UK consumers, supplied via online marketplaces and by specialist retailers. This review did not find any evidence of product safety concerns raised by Trading Standards or Citizens Advice, and OPSS had not received notifications about support belts to our Product Safety Database from other regulators.”

    Source location

    Response from Office for Product Safety and Standards
    Page 2 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Write to major online marketplaces about inadequate instructions and warnings, and alert them that the ORTONES belt should not be supplied.

    Verbatim wording from the response

    “On this basis, OPSS is taking further action on this product category. We have written to major online marketplaces, including Amazon, eBay, Temu, Shein and Alibaba, to make them aware that certain products may not be provided with suitable instructions or warnings to assure safe use by likely users. This will assist online marketplaces to identify whether these products are available on their platforms and take action to update or remove relevant listings. OPSS has also alerted online marketplaces to our Product Safety Report published for the ORTONES belt to make clear this product should not be supplied. OPSS has highlighted our activity for these products to relevant stakeholders, including Age UK and the Royal Society for the Prevention of Accidents.”

    Source location

    Response from Office for Product Safety and Standards
    Page 2 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Highlight activity concerning support-belt safety to relevant stakeholders, including Age UK and the Royal Society for the Prevention of Accidents.

    Verbatim wording from the response

    “On this basis, OPSS is taking further action on this product category. We have written to major online marketplaces, including Amazon, eBay, Temu, Shein and Alibaba, to make them aware that certain products may not be provided with suitable instructions or warnings to assure safe use by likely users. This will assist online marketplaces to identify whether these products are available on their platforms and take action to update or remove relevant listings. OPSS has also alerted online marketplaces to our Product Safety Report published for the ORTONES belt to make clear this product should not be supplied. OPSS has highlighted our activity for these products to relevant stakeholders, including Age UK and the Royal Society for the Prevention of Accidents.”

    Source location

    Response from Office for Product Safety and Standards
    Page 2 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Continue monitoring evidence and engaging UK retailers and manufacturers to promote clear instructions and warnings and safer foreseeable use.

    Verbatim wording from the response

    “OPSS is continuing to monitor the available evidence and engage with retailers and manufacturers in the UK, to ensure products are supplied with clear and appropriate instructions and warnings and do not pose a risk when they are used normally and foreseeably.”

    Source location

    Response from Office for Product Safety and Standards
    Page 2 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Write to the Office of Product Safety and Standards expressing concerns about the lap belt product.

    Verbatim wording from the response

    “I will be writing to the Office of Product Safety and Standards with my deep concerns about the product in question. You may also like to make the OPSS aware of your concerns.”

    Source location

    Response from DHSC
    Page 1 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review the relevant safety standard and ORTONES belt instructions for warnings concerning prescription, fitting, skin injury and strangulation risks.

    Verbatim wording from the response

    “Warnings. We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840-15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.”

    Source location

    Response from The Medicine and Healthcare Products and Regulatory Agency
    Page 4 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Advise OPSS of concerns about support belts and highlight the missing safety information in the ORTONES belt instructions.

    Verbatim wording from the response

    “Given this, the MHRA has advised the relevant regulator, the Office of Product Safety and Standards (OPSS), to ensure that they are aware of your concerns.”

    Source location

    Response from The Medicine and Healthcare Products and Regulatory Agency
    Page 4 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Inform OPSS about the ongoing investigation and include it in manufacturer communications to assess proposed corrective actions.

    Verbatim wording from the response

    “Eurobaston S.L. has committed to the re-evaluation of the ORTONES belt design, labelling and instructions for use. Eurobaston S.L. have informed us that they will be working with Comercial Nespral S.L to determine what corrective actions can be implemented for ORTONES belts that have been distributed in the UK. The MHRA will inform OPSS of this ongoing investigation into the sale of support belts without the appropriate warnings, including the ORTONES belt. In addition, we will include OPSS in our communications with the Eurobaston S.L, to assess the appropriateness of their corrective actions.”

    Source location

    Response from The Medicine and Healthcare Products and Regulatory Agency
    Page 6 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Responsibility for concerns about lap belt product advertising, sale, warnings and safety information sits with another organisation.

    Verbatim wording from the response

    “The report raises concerns over the advertisement and sale of the lap belt products which led to Mrs Lakin’s death, and the lack of warning and information around the dangers that could arise from their use. Officials within the Department of Health and Social Care have considered these concerns and concluded that the responsibility for these concerns sits within another organisation. I understand the Medicines and Healthcare products Regulatory Agency (MHRA) is also responding to your report, and I hope that their response will be helpful.”

    Source location

    Response from DHSC
    Page 1 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Support belts marketed for general accident prevention are generally unlikely to qualify as medical devices or accessories under UK regulations.

    Verbatim wording from the response

    “The MHRA’s Borderline team have reviewed the intended use and claims of the ORTONES belt and concluded that wheelchair belts are unlikely to meet the definition of a medical device in their own right, as the intended purpose is to prevent accidents and falls, which is not considered to be a medical purpose.”

    Source location

    Response from The Medicine and Healthcare Products and Regulatory Agency
    Page 3 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Addressing missing warnings for belts not classified as medical devices or accessories is outside the regulator’s remit.

    Verbatim wording from the response

    “Warnings. We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840-15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.”

    Source location

    Response from The Medicine and Healthcare Products and Regulatory Agency
    Page 4 · response
    Published 17 April 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The Office of Product Safety and Standards is the relevant regulator for concerns about unregulated supportive belts and their warnings.

    Verbatim wording from the response

    “In addition to the concerns regarding the ORTONES belt, we have identified several other supportive belts that are sold online that do not appear to be registered with the MHRA. However, they also make general claims, similar to the ORTONES belt, and are therefore unlikely to qualify as medical devices or accessories to a medical device.”

    Source location

    Response from The Medicine and Healthcare Products and Regulatory Agency
    Page 4 · response
    Published 17 April 2025

    Open published response
  2. North Wales (East and Central)

    AI-generated summary

    Emma Louise Powell · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Emma Louise Powell got into difficulties while paddleboarding at Conwy Morfa on 14 July 2022 and was recovered after being submerged for more than ten minutes. The inquest evidence raised concerns that she was not wearing life-saving equipment, used an inappropriate ankle leash in fast-flowing water, and had received no safety advice at the point of sale about safety vests or leash positioning.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of mandatory safety advice for paddleboard purchasers at retail sale

    Wider context from the report

    “The evidence at inquest indicated that Miss Powell had purchased a paddleboard from Tesco at Llandudno Junction on the evening of the 14th of July 2022, that she had taken it to Conwy Morfa and had thereafter used it in an unsafe manner, whereby she did not wear any life saving equipment and the safety leash on the board was by way of an ankle leash which was inappropriate for the fast flowing water. The evidence further indicated that at the point of sale, there was no safety advice or guidance provided in relation to either the advisory wearing of a safety vest, or the need to be aware that the positioning of a safety leash should take into account the environment/water conditions where the paddleboard is to be used as per the below information: Unless action is taken to improve the provision of information to purchasers of paddleboards and/or to regulate the sale of paddleboards to ensure that the provision of advice of this nature becomes a mandatory requirement at the point of retail sale, then there is an ongoing risk that further accidents will occur and that lives may be lost as a result. ”

    Source location

    Emma Louise Powell · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review the paddleboard products and accompanying safety information, including warnings.

    Verbatim wording from the response

    “Tesco sell two paddleboard products which are branded from a single supplier and are not Tesco lines. We only sell these in a limited number of our large Extra and Superstores that are at 'waterside' locations. Following your letter (and in fact before we received it, based on the media reports on your Hearing) we have been working with our supplier to review the products and information, including safety warnings, accompanying them. Based on this review, we have concluded that the products are safe and have appropriate instructions. However we have agreed with the supplier that a sticker will be added to the front of the product packaging with the following information:”

    Source location

    Response from Tesco
    Page 1 · response
    Published 4 January 2023

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Add front-of-package safety stickers with life-jacket, buoyancy-aid, leash-use warnings and a QR code, then distribute or affix them to product units.

    Verbatim wording from the response

    “Tesco sell two paddleboard products which are branded from a single supplier and are not Tesco lines. We only sell these in a limited number of our large Extra and Superstores that are at 'waterside' locations. Following your letter (and in fact before we received it, based on the media reports on your Hearing) we have been working with our supplier to review the products and information, including safety warnings, accompanying them. Based on this review, we have concluded that the products are safe and have appropriate instructions. However we have agreed with the supplier that a sticker will be added to the front of the product packaging with the following information:”

    Source location

    Response from Tesco
    Page 1 · response
    Published 4 January 2023

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Refer the report to Hertfordshire Trading Standards to determine whether further action is needed.

    Verbatim wording from the response

    “Your Report states that there was no evidence that there was advice or instruction given at the point of sale on the safe use of the product. As stated there are obligations and duties on both manufacturers and distributors to ensure adequate advice is provided. I have therefore referred your Report to Hertfordshire Trading Standards, the Primary Authority responsible for the regulatory relationship with Tesco, so that they may decide if any further action is needed in addition to that already taken in this specific case.”

    Source location

    Response from Department for Business & Trade
    Page 2 · response
    Published 4 January 2023

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Ask OPSS to write to the Business Reference Panel about distributors’ awareness of paddleboard safety obligations.

    Verbatim wording from the response

    “I have also asked the Office for Product Safety and Standards (OPSS) to write to the Business Reference Panel, that includes the British Retail Consortium and a number of major retailers, such as Tesco, to ensure that distributors are aware of this issue and their obligations.”

    Source location

    Response from Department for Business & Trade
    Page 2 · response
    Published 4 January 2023

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Ask OPSS to liaise with enforcement partners and, where appropriate, manufacturers about awareness of the incident and potential action.

    Verbatim wording from the response

    “In addition, I have asked OPSS to liaise with their enforcement partners, and through them where appropriate manufacturers, to ensure that there is awareness of this incident so that if necessary appropriate action can be taken.”

    Source location

    Response from Department for Business & Trade
    Page 2 · response
    Published 4 January 2023

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The paddleboard products are considered safe and already have appropriate instructions.

    Verbatim wording from the response

    “Tesco sell two paddleboard products which are branded from a single supplier and are not Tesco lines. We only sell these in a limited number of our large Extra and Superstores that are at 'waterside' locations. Following your letter (and in fact before we received it, based on the media reports on your Hearing) we have been working with our supplier to review the products and information, including safety warnings, accompanying them. Based on this review, we have concluded that the products are safe and have appropriate instructions. However we have agreed with the supplier that a sticker will be added to the front of the product packaging with the following information:”

    Source location

    Response from Tesco
    Page 1 · response
    Published 4 January 2023

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Hertfordshire Trading Standards will decide whether further enforcement action is needed regarding paddleboard safety advice and point-of-sale information.

    Verbatim wording from the response

    “Your Report states that there was no evidence that there was advice or instruction given at the point of sale on the safe use of the product. As stated there are obligations and duties on both manufacturers and distributors to ensure adequate advice is provided. I have therefore referred your Report to Hertfordshire Trading Standards, the Primary Authority responsible for the regulatory relationship with Tesco, so that they may decide if any further action is needed in addition to that already taken in this specific case.”

    Source location

    Response from Department for Business & Trade
    Page 2 · response
    Published 4 January 2023

    Open published response
  3. West Yorkshire (Western)

    AI-generated summary

    Brian Leonard Bicat · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Brian Leonard Bicat sustained severe burns at home on 22 September 2017 when his dressing gown caught fire while he was smoking a cigarette. He died later that day from his extensive cutaneous burns, with evidence indicating that paraffin-based emollient creams and ointments increased the speed and intensity of the fire. The principal concerns were that low-paraffin emollients may pose a fire hazard, that warnings were not displayed consistently on packaging or communicated by healthcare professionals, and that related prescribing alerts and incident data were inconsistent or incomplete.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Unavailability of verbal fire-risk warnings from healthcare professionals for retail and online purchases

    Wider context from the report

    “Members of the public are able to purchase such products in retail outlets and online where verbal warnings from healthcare professionals are not given ”

    Source location

    Brian Leonard Bicat · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Update personnel communicating with healthcare professionals and the public on the assessment outcome and subsequent labelling changes.

    Verbatim wording from the response

    “Any and all personnel in contact with healthcare professionals and the general public will be updated appropriately to ensure communications are in line with, and convey, the correct message which communicates the outcome of the assessment and any subsequent labelling changes.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Other recipients of the report will address concerns about healthcare warnings, prescribing systems, incident data and fire-safety training.

    Verbatim wording from the response

    “Bayer's response to items 1-5 is provided below. We understand that other recipients of the Report will address items 6-12.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 4 · response
    Published 30 October 2018

    Open published response
  4. West Yorkshire (West)

    AI-generated summary

    Pauline Taylor · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Pauline Taylor, who was bedbound and living alone, died in her home after a fire developed around her bed on 30 May 2015. The report identified concerns about the fire risks of low-paraffin emollient creams, limited warnings and awareness of those risks, the contribution of the airflow mattress, and the absence of a further risk assessment after her circumstances changed.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to verbally inform over-the-counter purchasers of fire hazards from low-paraffin emollient creams

    Wider context from the report

    “(4) Members of the public are able to purchase emollient creams across the counter but are not verbally made aware of the potential fire hazards of emollient cream containing a low level of paraffin. ”

    Source location

    Pauline Taylor · Prevention of Future Deaths report
    Page 4 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Warnings on emollient packaging and to the general public are matters for other recipients with a broader remit.

    Verbatim wording from the response

    “This is the Response of Locala Community Partnerships. As an organisation we have considered the content of your report very carefully. We note that at section 5 you have raised a number of matters of concern relating to zerobase and other emollient creams which whilst containing potentially a relatively low level of paraffin, still pose a potential fire hazard risk. We note the recommendations concerning warnings on the packaging and to members of the public at large, who as you note are able to purchase many such creams over the counter. Locala would support the raising of awareness in this area and if it is permissible, would be interested to see the responses that you obtain from the other recipients of your Regulation 28 report that have a broader remit.”

    Source location

    2017-0330-Response-by-Locala_Redacted
    Page 1 · response
    Published 21 July 2017

    Open published response
Back to top

Data last updated 7 September 2026